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ProKidney, a trailblazer in the cellular therapeutics landscape, has recently announced its plans to acquire a manufacturing facility in Greensboro, North Carolina. This move is expected to support the company's expansion strategies and future manufacturing requirements, particularly for their proprietary REnal Autologous Cell Therapy, REACT®.
About ProKidney
ProKidney, established in 2018, is a leading player in the field of cellular therapeutics, particularly in the treatment of chronic kidney disease (CKD). Their groundbreaking work revolves around the development of their lead product, REACT® (Renal Autologous Cell Therapy), a novel patented autologous cellular therapy that could potentially help preserve kidney function in patients at risk of kidney failure.
The Acquisition
The company has entered into an agreement to purchase a 210,000 square foot facility along with approximately 22 acres of land in Greensboro, N.C. The facility, which comes with a price tag of approximately $25.5 million, is expected to support ProKidney's future commercial manufacturing needs for REACT®. The transaction is anticipated to close by June 2023, following the fulfilment of customary closing conditions.
Strategic Buildout
"This acquisition signifies an important aspect of our strategic manufacturing expansion," ProKidney's CEO, Dr. Tim Bertram, commented. He outlined a staged investment plan that hinges on the successful clinical trials of REACT, potential regulatory approval, and commercial demand. If approved, the Greensboro facility, coupled with their existing Winston-Salem facility, is projected to produce enough REACT to meet initial commercial demand.
Future Plans
Bertram further elucidated ProKidney’s future plans, stating that the company is preparing for a potential shift to a commercial organization, contingent upon the outcomes of the proact 1 and proact 2 clinical trials. The company aims to submit a Biological Licensing Agreement (BLA) for FDA approval of REACT in 2026, with a projected commercial launch in the U.S. later that year.
Incentive Package
As part of the purchase agreement, ProKidney is eligible to receive an incentive package approved by the city of Greensboro, N.C., Guilford County, N.C., and the North Carolina State Economic Investment Committee. The package could yield up to $13.3 million in tax credits for ProKidney, provided they meet certain milestones, such as creating at least 330 new jobs by December 31, 2028, and making project investments of approximately $458 million by December 31, 2027.
Financial Projections
ProKidney's financial outlook remains steady, with the company expecting funds as of March 31, 2023, to support operations through the reporting of interim results from proact 1, anticipated to be released in late 2024.
ProKidney Innovations
ProKidney's work in cellular therapy is expected to revolutionize CKD treatment. Their lead product, REACT, is a first-of-its-kind, patented autologous cellular therapy specifically designed to preserve kidney function in at-risk patients. This product targets late-stage CKD patients (Stage 3b - 4) and has received support from the FDA and EMA, as well as a Regenerative Medicine Advanced Therapy (RMAT) designation.
Chronic Kidney Disease: A Global Issue
CKD is a major global health concern, affecting an estimated 75 million people in the U.S. and Europe and over 400 million people across Asia. In fact, CKD is one of the most significant expenses for the U.S. healthcare system. The disease often leads to a progressive decline in kidney function, ultimately necessitating renal replacement therapy, such as hemodialysis or kidney transplant.
The Future of Kidney Treatment
The work being done by ProKidney is expected to bring a new era of treatment for CKD. With their pioneering work in cellular therapy, the company aims to significantly improve the lives of CKD patients and reduce the burden on the healthcare system.
Conclusion
The acquisition of the Greensboro facility is a significant milestone for ProKidney, setting the stage for their expansion and future commercial manufacturing needs for REACT. The company's innovative approach to treating CKD could potentially change the lives of millions suffering from this debilitating disease.
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